Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues
Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of medical procedure kits containing syringes with material defects (leaks, breakage, quality issues) that pose a risk to patient health. No hospitalization or injury reports are mentioned in the source, placing this at the High severity level for a risk-of-harm device recall without reported harm.
Plain-English summary
Medline Industries, LP is recalling 9,246 units of medical procedure kits containing plastic syringes. The recalled kits are marketed under 34 different pack numbers and are used in cardiac catheterization, angiography, and interventional radiology procedures.
The plastic syringes in these kits are affected by an FDA Safety Alert issued on March 19, 2024. The syringes exhibit leaks, breakage, and other quality issues that may pose a risk to patient health.
The affected kits have been distributed nationwide in the United States and in Canada. Each recalled kit variant has a specific UDI (Unique Device Identifier) code and lot number for identification.
The recalled product
- Product
- Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 9,246
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) Pack Number DYNJ47718D: UDI/DI 10195327528331 (each) 40195327528332 (case)
- Lot Number 23LME887A
- 2) Pack Number DYNJ69678: UDI/DI 10193489968156 (each) 40193489968157 (case)
- Lot Number 23EMD520A
- 3) Pack Number DYNJ64936A: UDI/DI 10193489978759 (each) 40193489978750 (case)
- Lot Number 21LBW389A
- 4) Pack Number DYNJ49621C: UDI/DI 10195327008581 (each) 40195327008582 (case)
- Lot Number 23LMG954A
- 5) Pack Number DYNJ61266A: UDI/DI 10195327057763 (each) 40195327057764 (case)
- Lot Number 23GBF536A
- 6) Pack Number DYNJ35916N: UDI/DI 10195327223977 (each) 40195327223978 (case)
- Lot Number 23EBE626A
- 7) Pack Number DYNJ34442F: UDI/DI 10193489881424 (each) 40193489881425 (case)
- Lot Number 23LMG342A
- 8) Pack Number DYNJ53588I: UDI/DI 10195327014001 (each) 40195327014002 (case)
- Lot Number 23EME005A
- 9) Pack Number DYNJ31733C: UDI/DI 10889942875290 (each) 40889942875291 (case)
- Lot Number 21BBG459B
- 10) Pack Number DYNJ41315A: UDI/DI 10888277907089 (each) 40888277907080 (case)
- Lot Number 22LBA182A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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